USER MANUAL - Precision Medical
Contents
1. LIMITED WARRANTY AND LIMITATION OF LIABILITY Precision Medical Inc warrants that the EasyPulse5 Oxygen Conserving Regulator the Product will be free of defects in workmanship and or material for the following periods Two 2 years from date of shipment Should any failure to conform to this warranty appear within the applicable period Precision Medical Inc shall upon written notification thereof and substantiation that the goods have been stored installed maintained and operated in accordance with Precision Medical Inc s instructions and standard industry practice and that no modifications substitutions or alterations have been made to the goods correct such defect by suitable repair or replacement at its own expense ORAL STATEMENTS DO NOT CONSTITUTE WARRANTIES The representative of Precision Medical Inc or any retailers are not authorized to make oral warranties about the merchandise described in this contract and any such statements shall not be relied upon and are not part of the contract for sale Thus this writing is a final complete and exclusive statement of the terms of that contract THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ANY WARRANTY OF MERCHANTABILITY FITNESS FOR A PARTICULAR PURPOSE OR OTHER WARRANTY OF QUALITY WHETHER EXPRESS OR IMPLIED Precision Medical Inc shall not under any circumstances be liable for special incidental or consequential damages including but not limite2. 3 2 3 of full scale No Gauge Models Gauge Models 10 oz 283 g 12 6 oz 357 g 2 5 in 6 4 cm 2 4 in 6 0 cm 1 9 in 4 9 cm 2 8 in 7 0 cm 2 9 in 7 5 cm 3 2 in 8 1 cm 1 2 3 4 amp 5 lom Equivalents 2 lpm Continuous Within 15 of the nominal bolus value at each breath rate 2 Ipm 10 Up to 5 7 1 Inspiratory effort Negative pressure from patient inhalation UP to 35 bpm Maximum 7 foot 2 1 m long standard adult single lumen nasal cannula 35 F to 105 F 1 7 C to 40 6 C Sea level to 10 000 ft 0 to 3 048 m 40 F to 140 F 40 C to 60 C 95 Non condensing CGA 540 Valve DIN 477 6 Valve Swedish Standard DIN 477 9 Valve German Standard British Bullnose Valve Spanish Bullnose Valve Meets ASTM G175 03 Specifications are subject to change without prior notice EASYPULSE5 6 Oxygen Conserving Regulator DIAGRAMS COMPONENT DESCRIPTION ACAUTION Missing or illegible labels must be replaced contact Precision Medical Inc MODELS 3 versions shown CGA 540 Connection 195405 Shown and 194504NG Inlet Seal Cannula Co O ring Connection Z Dial ox SSE Contents Gauge L Gauge Models Indicato Y j ONLY Baer Denge Green 3 Knob DIN 477 6 Connection Swedish Standard 19SE05 Shown and 19SEO5NG Labels are Green amp White DIN 477 9 Connection German Standard 19DE05
3. CONSULT ACCOMPANYING DOCUMENTS Symbol for USE NO OIL Symbol for NO SMOKING Symbol for COVERING DEVICE WITH GARMENTS WILL PRODUCE OXYGEN ENRICHED ATMOSPHERE Symbol for SINGLE USE Symbol indicates the device complies with the requirements of Directive 93 42 EEC concerning medical devices and all applicable International Standards On CE marked Devices ONLY 3 AWARNING ALWAYS confirm prescribed dose before administering to patient and monitor on a frequent basis Always follow standards for Medical Gas Products and High Pressure Oxygen Handling In the United States ANSI CGA and G 4 applies Keep cylinder valve closed at all times when cylinder is not in use NO OXYGEN is delivered when the pointer V is aligned with OFF This Conserver is NOT to be used by patients who breathe through their mouths DO NOT use if dirt or contaminants are present on or around cylinder valve the Conserver or connecting devices DO NOT use oils greases organic lubricants or any combustible materials on or near the Conserver Wash and dry hands properly prior to use DO NOT use a humidifier with the Conserver DO NOT allow cylinders to tip or fall Secure gas cylinders so they cannot fall For optimum safety keep cylinder upright whenever possible DO NOT siore cylinders near sources of heat or flame DO NOT use while sleeping without consulting your Equipment Provider DO NOT smoke in an
4. and 19DEO5NG Labels are Black amp White Cannula Inlet Seal Connection O ring Dial Contents Gauge Gauge Models NLY ONLY Indicator Pointer White Knob FASYPULSE5 Bullnose Connection British 19GBO5 Shown and 19GBO5NG Spanish 19ES05 and 19ESO5NG inlet Seal Cannula D O ring Connection Dial 4 N A QOS Contents Gauge F Gauge Models ONLY Z d Indicator Aa J aa Ki Pointer E U i White Knob INSTALLATION AWARNING e Read this User Manual before installing or operating the Oxygen Conserving Regulator e Inspect the Conserver and cylinder valve to ensure they are free of oils greases or other contaminants e DO NOT direct flow of oxygen at any person or flammable material when cracking open the cylinder CAUTION e Inspect the Oxygen Conserving Regulator for visual damage before use DO NOT USE if damaged e DO NOT use tools to tighten knob this can lead to over tightening and will cause damage to the Conserver e Be sure all connections are tight and leak free e DO NOT use liquid leak detector to test for leaks NOTE For Operational Instructions on how to operate the cylinder consult with your Equipment Provider PULSES 8 Oxygen Conserving Regulator 1 Position the cylinder so the oxygen cylinder valve outlet is pointing away from the user and any other person s 2 Before installing the Conserver crac
5. area where oxygen is being administered DO NOT use near any type of flame or flammable explosive substances Use only medical grade oxygen In the United States USP applies The Conserver is equipped with a relief valve If you hear a loud hissing or popping sound coming from the Conserver discontinue use close cylinder valve and contact your Equipment Provider The Conserver is designed to operate with a single lumen adult cannula with a maximum length of 7 feet 2 1 m The cannula is for single patient use only E ACAUTION e Only personnel instructed and trained in its use should operate the Conserver e The Conserver contains magnetic ferrous material that may affect the results of an MRI e DO NOT autoclave e DO NOT gas sterilize with Ethylene Oxide e DO NOT clean with aromatic hydrocarbons e Store the Conserver in a clean area when not in use e Avoid dropping the Conserver or placing it in a position where it could fall and become damaged e Consistent with the recommendations of the medical community on the use of conserving devices itis recommended that the Conserver be qualified on patients in the situations it will be used e The Conserver may not be able to detect all respiratory efforts of the patient Shallow breathers may not be able to trigger the Conserver e Operating the Conserver outside its range of operating conditions may affect its accuracy and performance PRINCIP
6. 10993 1 EN ISO 10993 5 EN ISO 10993 10 EN ISO 15001 ISO 10524 1 ISO 10524 3 ISO 14971 ISO 18779 ISO 228 1 SS 367615 Notified Body T V Rheinland Products Safety GmbH C 0197 EC Certificate No HD60019110 0001 ISO 13485 Certified 0197 504429 Rev10 12 08 10 2M PRINTED In USA
7. EASYPLLSES5 Oxygen Conserving Regulator 1900 Series Threaded Connections SAVE THESE INSTRUCTIONS Federal USA law restricts this device to sale ACAUTION by or on the order of a physician PRECISION MEDICAL 300 Held Drive Tel 001 610 262 6090 Northampton PA 18067 USA Fax 001 610 262 6080 www precisionmedical com CONTENTS RECEIVING INSPECTION eege EENS EEN 2 INTENDED US Eeer 2 READ ALL INSTRUCTIONS BEFORE UGIN 2 EXPLANATION OF ABBREVIATIONS A 2 SAFETY INFORMATION WARNINGS AND CAUTIONS ssaseeenn 3 PRINCIPLES OF OPERATION teeter teeceeeeeeeeetetetneaes 5 SPECIFICATIONS isscenniaieacesecssdtacesiscsgsnnssadeetsbsssovesantareuieseedieatevngeanconns 6 DIAGRAMS COMPONENT DESCRIPTION 0c eee eee 7 INSTALLATION cesses secciss cts deed ovaceecancderedensacncs aveenareny EE 8 OPERATING INSTRUCTION 9 MAINTENANCE CLEANING eee eee cere tee teeter teres eeeeeees 11 RETURN Skrien a a a S TA 11 DISPOSAL INSTRUCTIONS nvisuirssiciiissinisisnoiinicisininisiniridiivieisa 11 TROUBLESHOOTING sepiii aaoi 12 REPLACEMENT PART 12 ee 13 LIMITED WARRANTY tee ege gedoe dese te eege EE Ed 14 EE RECEIVING INSPECTION Remove the Precision Medical Inc EasyPulse5 Oxygen Conserving Regulator Conserver from the packaging and inspect for damage If there is any damage DO NOT USE and contact your Equipment Provider INTENDED USE To regulate high pressure cylinders that provide supplemental
8. LES OF OPERATION The Oxygen Conserver is designed to be used with high pressure oxygen systems It consists of a cylinder connection cylinder contents gauge if equipped high to low pressure regulator orifice plate anda conserving demand module The regulator reduces the high pressure of the cylinder to the working pressure of the orifice plate The orifice plate uses calibrated orifices to deliver a selected flow to the conserving demand module The conserving demand module controls the pulse size and timing to the patient It supplies a pulse of oxygen at the beginning of each breath This reduces the oxygen demand on the system and limits the drying of the airways The flow is determined by setting the flow control knob to the prescribed flow The oxygen is supplied to the patient through the cannula EASYPULSE5 Oxygen Conserving Regulate 5 SPECIFICATIONS Inlet Pressure Range Internal Regulated Pressure Pressure Gauge Accuracy Dimensions are Approximate and may vary by model Weight Overall Length Width Height Pulse Settings Flow Settings Accuracy Pulse Volume Continuous Setting Savings Ratio Trigger Method Breathing Frequency Cannula Requirement Operating Conditions Temperature Altitude Storage Conditions Temperature Maximum Humidity Oxygen Cylinder Connection Ignition and Fault Tolerance psi kPa bar 300 3000 2068 20684 20 68 206 84 50 345 3 45
9. d to lost profits lost sales or injury to person or property Correction of non conformities as provided above shall constitute fulfillment of all liabilities of Precision Medical Inc whether based on contract negligence strict tort or otherwise Precision Medical Inc reserves the right to discontinue manufacture of any product or change product materials designs or specifications without notice Precision Medical Inc reserves the right to correct clerical or typographical errors without penalty EASYPULSE5 14 Oxygen Conserving Regulator DECLARATION OF CONFORMITY Manufacturer Precision Medical Inc 300 Held Drive Northampton PA 18067 USA CONTACT Quality Manager Phone 610 262 6090 Authorized European Representative Emergo Europe European Office Molenstraat 15 2513 BH The Hague The Netherlands Phone 31 0 70 345 8570 Fax 31 0 70 346 7299 Product EasyPulse5 Oxygen Conserving Regulators Model s 198705EN 195405 19DE05 19ES05 19ESO5 EN 19GB05 19SE05 19SE05 ES 198705NG 195405NG 19ESO5NG 19ESO5NG EN 19GBO5NG 19SEO5NG 19SEO5NG NO 19WMO0501 MDD Class llb Classification criteria Clause 3 2 Rule 11 of Annex IX of MDD As delivered the object of the declaration described above is in conformity with the requirements of MDD 93 42 EEC Annex II 3 Directive 2007 47 EC of THe European Parliament and the following documents BS 341 3 DIN 477 1 EN 837 1 EN 1041 EN 980 EN ISO
10. er V is aligned with the prescribed setting 5 Breathe through the nose you should feel a pulse of oxygen as you inhale NOTE e When on a pulse setting there is flow or a pulse only at the beginning of each breath If you do not feel the pulse at the beginning of each breath check the setting If there is still no pulse turn dial to 2 Ipm Continuous setting e Because each patient s breathing pattern is different and the environment varies it may be difficult to feel some low setting pulses 6 To remove the Conserver from cylinder e Completely close oxygen cylinder valve clockwise e Turn the Conserver dial to 2 lpm continuous position e Wait for oxygen to stop flowing from Conserver e Remove Conserver from cylinder valve A DANGER NEVER attempt to remove the Conserver from a cylinder unless the cylinder valve is closed AWARNING e When cylinder pressure is 500 psi 3447 kPa 34 47 bar and below it is recommended to change to a full oxygen cylinder e NO OXYGEN is delivered in between settings e To avoid injury to patient e ALWAYS confirm prescribed setting before administering to patient and monitor flow on a frequent basis N AWARNING e Use only Precision Medical Inc Carry Bag designed for the EasyPulse5 to prevent an oxygen enriched environment e DO NOT place the unit under clothing while in use e When the Conserver isin use asmallamount of oxygen is vented Wearing the unit under cloth
11. ging Please Recycle L 9 EE 11 TROUBLESHOOTING If the Conserver fails to function consult the Troubleshooting Guide below If problem cannot be solved consult your Provider TROUBLESHOOTING GUIDE 12 Problem Probable Cause Remedy A No flow Cylinder valve closed 1 Turn on cylinder Regulator in OFF 2 Set to prescribed position setting Cylinder empty 3 Replace cylinder Dial set between 4 Set dial so indicator V settings points to a setting Conserver not sensing 5 a Check position of breath cannula in nose b Do not breathe through mouth B Leaking at Missing or defective 1 Replace Inlet Seal cylinder Inlet Seal connection Defective cylinder 2 Contact your valve Equipment Provider REPLACEMENT PARTS DESCRIPTION PART Cannula 504833 Inlet Seals Viton O rings For models 195405 Serial 100461 or higher 505487 195405NG Serial 178367 or higher For models 19SE05 amp 19SEO5NG 505214 19DE05 amp 19DEO5NG 505401 19GB05 amp 19GBO5NG 505214 For models 19ES05 amp 19ESO5NG 505574 EE ACCESSORIES DESCRIPTION PART Carry Bag M6 503920 Carry Bag M4 M6 504184 Carry Bag ML6 M9 504185 Model 195405 Shown Model 195405NG Shown Carry Bag with shoulder strap Conserver properly installed in Carry Bag Conserver properly installed in Carry Bag FASYPULSE5 rar Cortsen ang Keier 13
12. ing may saturate fabrics with oxygen and cause them to burn rapidly if exposed to sparks or flame It may take several hours for oxygen levels in fabrics to return to normal e ALWAYS insert cylinder and the Conserver into bag cylinder first with gauge facing mesh Reference Accessory photo pg 13 EASYPULSE5 10 Oxygen Conserving Regulator MAINTENANCE CLEANING 1 Disconnect all connections before cleaning 2 After each use clean exterior of the Conserver with a cloth dampened with mild detergent and water 3 Wipe dry with a clean cloth 4 Store the Conserver in a clean area free from grease oil and other sources of contamination CAUTION e DO NOT use cleaning solutions e DO NOT immerse the Conserver in any kind of liquid e DO NOT attempt to repair the EasyPulse5 Oxygen Conserving Regulator e All repairs must be performed by Precision Medical Inc RETURNS Returned products require a Returned Goods Authorization RGA number contact Precision Medical Inc All returns must be packaged in sealed containers to prevent damage Precision Medical Inc will not be responsible for goods damaged in transit Refer to Precision Medical Inc Return Policy available on the Internet www precisionmedical com DISPOSAL INSTRUCTIONS This device and its packaging contain no hazardous materials No special precautions need to be taken when disposing the device and or its packa
13. k cylinder valve by opening the valve slightly to remove any foreign particles and then close valve NOTE For NO GAUGE NG Models ONLY The Conserver should only be used on cylinders with a contents gauge 3 Be sure the Conserver is in the OFF position Align OFF with the indicating pointer V 4 Be sure the high pressure inlet connection has a seal DO NOT USE without a seal See Product Diagram NOTE For optimum safety use only a Precision Medical Inc Inlet Seal Viton O ring See Parts List The Inlet Seal supplied with the Conserver is reusable DO NOT USE any other type of seal 5 Attach the Conserver to the oxygen cylinder valve 6 Hand tighten knob clockwise until tight OPERATING INSTRUCTIONS 1 Attach a standard adult single Lumen oxygen nasal cannula no longer than 7 feet 2 1 m to the Conserver s outlet according to the cannula manufacturer s instructions AWARNING e DO NOT use pediatric low flow nasal cannulas or oxygen masks with the Conserver e DO NOT block the cannula connection or kink cannula tubing when the Conserver is in use this may damage the Conserver 2 Place the cannula over your ears and position the prongs in your nose as instructed by your Healthcare Provider or Cannula manufacturer FASYPULSE5 Oxygen Conserving Regulate 9 3 Slowly open cylinder valve counterclockwise until completely open 4 Turn dial on the Conserver until indicating point
14. oxygen to patients who may have difficulty extracting oxygen from the air they breathe It is for patients who would normally receive the oxygen via a nasal cannula The device delivers 100 oxygen at flow settings It is intended to be used as an oxygen saving device that reduces the drying of the airways READ ALL INSTRUCTIONS BEFORE USING This manual instructs the user to install and operate the Oxygen Conserving Regulator Conserver This is provided for your safety and to prevent damage to the Conserver If you do not understand this manual DO NOT USE the Conserver and contact your Equipment Provider ADANGER This product is not intended as a life sustaining or life supporting device EXPLANATION OF ABBREVIATIONS kPa Kilopascal psi Pounds Per Square Inch lpm Liters Per Minute bpm Breaths Per Minute EE SAFETY INFORMATION WARNINGS AND CAUTIONS ADANGER AWARNING ACAUTION CAUTION AN S OOOX lt e NX EE Indicates an imminently hazardous situation which if not avoided will result in death or serious injury Indicates a potentially hazardous situation which if not avoided could result in death or serious injury Indicates a potentially hazardous situation which if not avoided may result in minor or moderate injury Used without the safety alert symbol indicates a potentially hazardous situation which if not avoided may result in property damage
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